Gastrotomy closure with the lock-it system and the Padlock-G clip: a survival study in a porcine model.

ABSTRACT

BACKGROUND AND STUDY AIMS: The success of natural orifice surgery depends on secure closure of the transmural gut opening, so a rapid, secure, and easy-to-place closure method is desirable. Our aim was to determine whether a gastrotomy can be closed safely and effectively from within the stomach in a survival model by using a novel, endoscopically placed device the Padlock-G system. PATIENTS AND METHODS: This was a pilot study of 4 survival animals in an animal laboratory setting. Gastrotomies were made in the stomachs of laboratory swine, and the abdomen was explored by using a standard gastroscope. Gastrotomies were then closed by using the Padlock-G system. Survival for 2 or 6 weeks was the primary outcome measurement. Secondary outcomes included ease of use, visual assessment of closure integrity immediately and at necropsy, presence of adhesions, evidence of infection, and histologic appearance at the closure sites. RESULTS: All animals thrived, ate normally, and gained weight. None developed fever, tachycardia, or signs of peritoneal irritation. Closure-site inspection at necropsy revealed excellent healing, with epithelial growth over the Padlock-G. There were no ulcers, serosal surfaces were tightly closed, and no defects could be seen. There were no signs of peritoneal inflammation, intra-abdominal adhesions, or gastric spillage. Histologic evaluation showed organizing granulation tissue with fibrosis, vascular proliferation, and mild chronic inflammatory infiltrate (i.e., scar). CONCLUSIONS: The Padlock-G is easy to place, provides a durable closure, and allows survival animals to thrive without adverse sequellae. This device provides a suitable closure system for transgastric NOTES.